FDA’s Approval of COVID-19 Treatment Should Be Promptly Revisited in Consultation with Outside Experts

WASHINGTON, D.C.  The U.S. Food and Drug Administration (FDA) should promptly convene an external expert advisory panel to evaluate whether the approval of the antiviral COVID-19 treatment remdesivir should be rescinded, Public Citizen said today in a letter to the agency.

“The FDA’s previous failure to convene its own public advisory committee to consider whether to approve remdesivir was inexcusable,” said Michael Abrams, M.P.H., Ph.D., a health researcher in Public Citizen’s Health Research Group, and lead author of the letter. “This failure is particularly troubling given that the agency was aware of evidence from a major clinical trial that raised substantial doubts about whether the drug provides clinically meaningful benefit.”

The letter requests that FDA Acting Commissioner Janet Woodcock convene a public meeting of the FDA’s Antimicrobial Drugs Advisory Committee to review the agency’s October 2020 decision to fully approve remdesivir, which was already available to patients in the U.S. under an Emergency Use Authorization (EUA). Public Citizen contends that based on the available evidence regarding the effectiveness of remdesivir, this full approval decision was not justifiable.

The letter notes that only two of the five trials reviewed by the FDA prior to approval showed that remdesivir reduced the length of hospitalization for a subset of COVID-19 patients, and no trials show that remdesivir reduced death rates from COVID-19. The largest trial reviewed was conducted by the World Health Organization showed no benefit of remdesivir in reducing deaths or the length of hospital stays.

Public Citizen’s letter calls on the agency to ask its expert public advisory committee whether the approval of remdesivir should be rescinded and whether the drug should be allowed to remain available under a much more limited EUA.